Rapamycin and il-10 for the treatment of immune diseases

Abstract

The invention discloses a combined preparation containing IL-10 and rapamucin able to induce immunosuppression and antigen-specific immune tolerance, and the use thereof in the treatment of diseases involving an excessive, dysfunctional or uncontrolled immune response mediated by T cells.

1 . A combined pharmaceutical preparation containing IL-10 and rapamycin, analogs, derivatives or conjugates thereof, for use in the modulation of T cell-mediated immune responses.  
   
   
       2 . A pharmaceutical preparation according to  claim 1 , for simultaneous, separate or sequential use in the preventive or therapeutic treatment of diseases involving an excessive, dysfunctional or uncontrolled self-or non-self T cell mediated immune responses.  
   
   
       3 . A pharmaceutical preparation according to  claim 2 , for simultaneous, separate or sequential use in the preventive or therapeutic treatment of allogeneic organ rejection, allograft β-islets rejection, graft versus host disease, and type I diabetes.  
   
   
       4 . A pharmaceutical preparation according to  claim 2 , for simultaneous, separate or sequential use in the preventive or therapeutic treatment of autoimmune diseases selected from rheumatoid arthritis, multiple sclerosis, systemic lupus erithematosus; chronic inflammatory diseases; inflammatory bowel diseases selected from Crohn's disease and ulcerative colitis; chronic obstructive pulmonary diseases; allergic diseases selected from asthma and atopic dermatitis, fibrotic diseases; and immune reactions to gene therapy derived products.  
   
   
       5 . A pharmaceutical preparation according to  claim 1 , further comprising an active substance selected from immunosuppressive or immunomodulating agents, antibodies and cytokines.  
   
   
       6 . A pharmaceutical preparation according to  claim 5 , wherein said active substance is selected from cyclosporine, FK506, pimecrolimus, mycofenolate, antibodies against CD45, LFA-1 molecules or the IL-2 receptor.  
   
   
       7 . A pharmaceutical preparation according to  claim 6 , containing antibodies to the IL-2 receptor alpha, beta, and gamma chains.  
   
   
       8 . A pharmaceutical composition containing IL-10 and rapamycin, or analogs, derivatives or conjugates thereof, together with pharmaceutically acceptable excipients.  
   
   
       9 . A pharmaceutical composition according to  claim 8 , which is in the form of solution, suspension, tablet or capsule.  
   
   
       10 . The use of a combination of IL-10 and rapamycin, or analogs, derivatives or conjugates thereof, for the preparation of an immune-modulating agent.  
   
   
       11 . The use according to  claim 10 , for the preparation of an immune-suppressive agent.  
   
   
       12 . The use according to  claim 11 , wherein the immune-suppressive agent induces antigen-specific immune tolerance.  
   
   
       13 . The use according to  claim 11 , wherein the immunosuppression and antigen-specific immune tolerance is mediated by Tr1 cells and/or CD4+CD25+ Tr cells.  
   
   
       14 . The use according to  claim 12 , wherein the immunosuppression and antigen-specific immune tolerance is mediated by Tr1 cells and/or CD4+CD25+ Tr cells.